IP Library › Granted Patent US 12,447,241
Granted Patent B2
US 12,447,241 · App. 16/936,554 · Granted Oct 21, 2025

Multi-unit drug delivery devices and methods

Inventors: Heejin Lee (Bedford, MA); Karen Daniel (Newton, MA); Matthew Sansone (Dracut, MA)
Assignee: TARIS Biomedical LLC
A61L31/16A61K9/0004A61K9/0034A61K31/7068A61K47/18A61L31/048A61L31/08A61M31/002A61K9/0092
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,447,241
App. No.
16/936,554
Granted
Oct 21, 2025
Kind
B2
Abstract

Implantable drug delivery devices include a housing defining a reservoir, a first unit within the reservoir, and a second unit within the reservoir. The first unit contains a drug and the second unit contains a functional agent that facilitates release of the drug. Intravesical drug delivery devices include a housing portion containing a drug formulation and a housing portion containing an excipient, and are configured to release the drug according to a first release profile and the excipient according to a second release profile. Methods include inserting any of these devices into a patient and releasing drug from the device.

Claims (15)

1. A drug formulation consisting of:

a first plurality of mini-tablets each consisting of:

80.0% by weight gemcitabine HCI;

13.3% by weight urea;

4.2% by weight polyvinylpyrrolidone; and

2.5% by weight polyethylene glycol 8000; and

a second plurality of mini-tablets each consisting of:

90% by weight urea; and

10% by weight one or more excipients.

2. The drug formulation of claim 1 , wherein each of the first and second pluralities of mini-tablets has a diameter between 1.5 mm and 3.1 mm.

3. The drug formulation of claim 2 , wherein each of the first and second pluralities of mini-tablets has a length between 2.0 mm and 4.5 mm.

4. The drug formulation of claim 1 , wherein each of the first and second pluralities of mini-tablets has a diameter of about 2.64 mm.

5. The drug formulation of claim 4 , wherein each of the first and second pluralities of mini-tablets has a length between 2.0 mm and 4.5 mm.

6. The drug formulation of claim 5 , wherein each of the first and second pluralities of mini-tablets has an aspect ratio of height: width of 3:2.

7. The drug formulation of claim 1 , wherein each of the first and second pluralities of mini-tablets has an aspect ratio of height: width from 3:2 to 5:2.

Assignments (5)
MERGER Recorded Jun 1, 2026
From: TARIS BIOMEDICAL LLC
To: JANSSEN BIOTECH, INC.
Reel/Frame 074811/0001 →
MERGER Recorded May 12, 2026
From: TARIS BIOMEDICAL LLC
To: JANSSEN BIOTECH, INC.
Reel/Frame 074630/0617 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 1, 2020
From: LEE, HEEJIN; DANIEL, KAREN; SANSONE, MATTHEW
To: TARIS BIOMEDICAL INC.
Reel/Frame 053951/0617 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 1, 2020
From: LIRIS BIOMEDICAL, INC.
To: TARIS BIOMEDICAL LLC
Reel/Frame 053951/0770 →
CHANGE OF NAME Recorded Oct 1, 2020
From: TARIS BIOMEDICAL INC.
To: LIRIS BIOMEDICAL, INC.
Reel/Frame 053967/0030 →
Continuity (4)
Continuation 14913185
Provisional Application 61867245 · Aug 19, 2013
Provisional Application 61877610 · Sep 13, 2013
Related Publication 20200353131A1 · Nov 12, 2020
References Cited (251)
US 3089815A · Hans et al. · 1963 [cited by applicant]
US 3625214A · Higuchi · 1971 [cited by applicant]
US 3675647A · Pharriss et al. · 1972 [cited by applicant]
US 3675648A · Pharriss et al. · 1972 [cited by applicant]
US 3710795A · Higuchi et al. · 1973 [cited by applicant]
US 3854480A · Zaffaroni · 1974 [cited by applicant]
US 3888975A · Ramwell · 1975 [cited by applicant]
US 3901232A · Michaels et al. · 1975 [cited by applicant]
US 3916899A · Theeuwes · 1975 [cited by examiner]
US 3935860A · Hoff · 1976 [cited by applicant]
US 3948254A · Zaffaroni · 1976 [cited by applicant]
US 4016251A · Higuchi et al. · 1977 [cited by applicant]
US 4111202A · Theeuwes · 1978 [cited by examiner]
US 4111203A · Theeuwes · 1978 [cited by applicant]
US 4210139A · Higuchi · 1980 [cited by applicant]
US 4235236A · Theeuwes · 1980 [cited by applicant]
US 4309996A · Theeuwes · 1982 [cited by applicant]
US 4326522A · Guerrero et al. · 1982 [cited by applicant]
US 4327725A · Cortese et al. · 1982 [cited by applicant]
US 4392848A · Lucas et al. · 1983 [cited by applicant]
US 4449980A · Millar et al. · 1984 [cited by applicant]
US 4475916A · Himmelstein · 1984 [cited by applicant]
US 4519801A · Edgren · 1985 [cited by examiner]
US 4578075A · Urquhart et al. · 1986 [cited by applicant]
US 4578263A · Whitehead · 1986 [cited by applicant]
US 4629449A · Wong · 1986 [cited by applicant]
US 4655219A · Petruzzi · 1987 [cited by applicant]
US 4678463A · Millar · 1987 [cited by applicant]
US 4681583A · Urquhart et al. · 1987 [cited by applicant]
US 4731054A · Billeter et al. · 1988 [cited by applicant]
US 4871542A · Vilhardt · 1989 [cited by applicant]
US 4936074A · Graham · 1990 [cited by examiner]
US 4968507A · Zentner et al. · 1990 [cited by applicant]
US 4973304A · Graham et al. · 1990 [cited by applicant]
US 5008112A · DePrince · 1991 [cited by applicant]
US 5057318A · Magruder · 1991 [cited by applicant]
US 5324280A · Wong et al. · 1994 [cited by applicant]
US 5340590A · Wong et al. · 1994 [cited by applicant]
US 5366738A · Rork et al. · 1994 [cited by applicant]
US 5441550A · Hassenboehler, Jr. et al. · 1995 [cited by applicant]
US 5458887A · Chen · 1995 [cited by examiner]
US 5499997A · Sharpe et al. · 1996 [cited by applicant]
US 5516522A · Peyman et al. · 1996 [cited by applicant]
US 5551954A · Bucemi et al. · 1996 [cited by applicant]
US 5709874A · Hanson et al. · 1998 [cited by applicant]
US 5788980A · Nabahi · 1998 [cited by applicant]
US 5795591A · Lee et al. · 1998 [cited by applicant]
US 5797898A · Santini, Jr. et al. · 1998 [cited by applicant]
US 5820230A · Freeman · 1998 [cited by applicant]
US 5851217A · Wolff et al. · 1998 [cited by applicant]
US 5855906A · McClay · 1999 [cited by applicant]
US 5869081A · Jackanicz et al. · 1999 [cited by applicant]
US 5879920A · Dale et al. · 1999 [cited by applicant]
US 5972372A · Saleh et al. · 1999 [cited by applicant]
US 5989581A · Groenewegen · 1999 [cited by applicant]
US 6039967A · Ottoboni et al. · 2000 [cited by applicant]
US 6039968A · Nabahi · 2000 [cited by applicant]
US 6083933A · Hahn · 2000 [cited by applicant]
US 6086909A · Harrison et al. · 2000 [cited by applicant]
US 6139535A · Greelis et al. · 2000 [cited by applicant]
US 6159143A · Lennox · 2000 [cited by applicant]
US 6168801B1 · Heil, Jr. et al. · 2001 [cited by applicant]
US 6171298B1 · Matsuura et al. · 2001 [cited by applicant]
US 6183461B1 · Matsuura et al. · 2001 [cited by applicant]
US 6207180B1 · Ottoboni et al. · 2001 [cited by applicant]
US 6283953B1 · Ayer · 2001 [cited by applicant]
US 6293923B1 · Yachia et al. · 2001 [cited by applicant]
US 6398718B1 · Yachia et al. · 2002 [cited by applicant]
US 6416780B1 · Passmore et al. · 2002 [cited by applicant]
US 6444224B1 · Rathbone et al. · 2002 [cited by applicant]
US 6464999B1 · Huo et al. · 2002 [cited by applicant]
US 6482837B1 · Wood · 2002 [cited by applicant]
US 6486204B2 · Waldstreicher et al. · 2002 [cited by applicant]
US 6491666B1 · Santini, Jr. et al. · 2002 [cited by applicant]
US 6524608B2 · Ottoboni et al. · 2003 [cited by applicant]
US 6682473B1 · Matsuura et al. · 2004 [cited by applicant]
US 6712784B2 · Huang · 2004 [cited by applicant]
US 6730072B2 · Shawgo et al. · 2004 [cited by applicant]
US 6746421B2 · Yachia et al. · 2004 [cited by applicant]
US 6749617B1 · Palasis et al. · 2004 [cited by applicant]
US 6753011B2 · Faour · 2004 [cited by applicant]
US 6808522B2 · Richards et al. · 2004 [cited by applicant]
US 6875208B2 · Santini, Jr. et al. · 2005 [cited by applicant]
US 6899890B2 · Kirschner et al. · 2005 [cited by applicant]
US 6932810B2 · Ryan · 2005 [cited by applicant]
US 6951654B2 · Malcolm et al. · 2005 [cited by applicant]
US 6973718B2 · Sheppard, Jr. et al. · 2005 [cited by applicant]
US 6976950B2 · Connors et al. · 2005 [cited by applicant]
US 6976951B2 · Connors et al. · 2005 [cited by applicant]
US 6988983B2 · Connors et al. · 2006 [cited by applicant]
US 7005138B2 · Mahashabde et al. · 2006 [cited by applicant]
US 7074178B2 · Connors et al. · 2006 [cited by applicant]
US 7207982B2 · Dionne et al. · 2007 [cited by applicant]
US 7232421B1 · Gambale et al. · 2007 [cited by applicant]
US 7316680B2 · Gilbert · 2008 [cited by applicant]
US 7521064B2 · Saxena et al. · 2009 [cited by applicant]
US 7647112B2 · Tracey et al. · 2010 [cited by applicant]
US 8343516B2 · Daniel et al. · 2013 [cited by applicant]
US 8603521B2 · Loury et al. · 2013 [cited by applicant]
US 9017312B2 · Lee et al. · 2015 [cited by applicant]
US 9757546B2 · Daniel et al. · 2017 [cited by applicant]
US 20030059456A1 · Malcolm et al. · 2003 [cited by applicant]
US 20030118649A1 · Gao et al. · 2003 [cited by applicant]
US 20030118692A1 · Wang et al. · 2003 [cited by applicant]
US 20030139800A1 · Campbell · 2003 [cited by applicant]
US 20030229263A1 · Connors et al. · 2003 [cited by applicant]
US 20040022824A1 · Li et al. · 2004 [cited by applicant]
US 20040034332A1 · Uhland · 2004 [cited by applicant]
US 20040149294A1 · Gianchandani et al. · 2004 [cited by applicant]
US 20040220552A1 · Heruth et al. · 2004 [cited by applicant]
US 20040260272A1 · Friedman et al. · 2004 [cited by applicant]
US 20050228482A1 · Herzog et al. · 2005 [cited by applicant]
US 20050234013A1 · Parsons · 2005 [cited by applicant]
US 20050234431A1 · Williams et al. · 2005 [cited by applicant]
US 20050238733A1 · Henry · 2005 [cited by applicant]
US 20060057208A1 · Holzer et al. · 2006 [cited by applicant]
US 20060105010A1 · Rahe et al. · 2006 [cited by applicant]
US 20060122689A1 · Kocur et al. · 2006 [cited by applicant]
US 20060234978A1 · Marcum · 2006 [cited by applicant]
US 20060259118A1 · Pal et al. · 2006 [cited by applicant]
US 20060264897A1 · Lobi et al. · 2006 [cited by applicant]
US 20060264912A1 · McIntyre et al. · 2006 [cited by applicant]
US 20070161967A1 · Fischer · 2007 [cited by applicant]
US 20070172507A1 · Zupkas et al. · 2007 [cited by applicant]
US 20070172508A1 · Zupkas et al. · 2007 [cited by applicant]
US 20070191818A1 · Dionne et al. · 2007 [cited by applicant]
US 20070202151A1 · Lee et al. · 2007 [cited by applicant]
US 20070207980A1 · Salama et al. · 2007 [cited by applicant]
US 20070254014A1 · Ahmed et al. · 2007 [cited by applicant]
US 20080051740A1 · Sokal et al. · 2008 [cited by applicant]
US 20080102119A1 · Grovender · 2008 [cited by examiner]
US 20080187590A1 · Vahervuo · 2008 [cited by examiner]
US 20090004246A1 · Woolfson et al. · 2009 [cited by applicant]
US 20090149833A1 · Cima et al. · 2009 [cited by applicant]
US 20090186081A1 · Holm et al. · 2009 [cited by applicant]
US 20090263441A1 · McKay · 2009 [cited by examiner]
US 20090317465A1 · Peppas · 2009 [cited by applicant]
US 20100003297A1 · Tobias et al. · 2010 [cited by applicant]
US 20100076261A1 · Neeman et al. · 2010 [cited by applicant]
US 20100247646A1 · Prasad · 2010 [cited by examiner]
US 20100331770A1 · Lee · 2010 [cited by examiner]
US 20110060309A1 · Lee et al. · 2011 [cited by applicant]
US 20110106006A1 · Martin et al. · 2011 [cited by applicant]
US 20110137244A1 · Lee et al. · 2011 [cited by applicant]
US 20110152839A1 · Cima et al. · 2011 [cited by applicant]
US 20110218488A1 · Boyko et al. · 2011 [cited by applicant]
US 20120089121A1 · Lee · 2012 [cited by examiner]
US 20120089122A1 · Lee et al. · 2012 [cited by applicant]
US 20120191068A1 · Himes et al. · 2012 [cited by applicant]
US 20120203203A1 · Lee et al. · 2012 [cited by applicant]
US 20140276636A1 · Lee et al. · 2014 [cited by applicant]
US 20150165177A1 · Giesing · 2015 [cited by applicant]
US 20150209277A1 · Lee et al. · 2015 [cited by applicant]
US 20150250717A1 · Giesing et al. · 2015 [cited by applicant]
US 20150291554A1 · Springer et al. · 2015 [cited by applicant]
DE 3332156A1 · 1985 [cited by applicant]
EP 0572932A2 · 1993 [cited by applicant]
EP 1982701A2 · 2008 [cited by applicant]
EP 1982701A3 · 2009 [cited by applicant]
JP 2012017308A · 2012 [cited by examiner]
WO 1997027840A1 · 1997 [cited by applicant]
WO 1997044021A1 · 1997 [cited by applicant]
WO 1998031415A1 · 1998 [cited by applicant]
WO 199901884A1 · 1999 [cited by applicant]
WO WO9963971A1 · 1999 [cited by examiner]
WO 2000040234A1 · 2000 [cited by applicant]
WO WO0154688A1 · 2001 [cited by examiner]
WO 2001067991A1 · 2001 [cited by applicant]
WO 2002000203A1 · 2002 [cited by applicant]
WO 2002005800A2 · 2002 [cited by applicant]
WO 02060421A2 · 2002 [cited by applicant]
WO 2002085428A2 · 2002 [cited by applicant]
WO 2003009882A2 · 2003 [cited by applicant]
WO 2004012699A2 · 2004 [cited by applicant]
WO 2004012699A3 · 2004 [cited by applicant]
WO 2004089457A1 · 2004 [cited by applicant]
WO 2004105854A1 · 2004 [cited by applicant]
WO 2005018697A2 · 2005 [cited by applicant]
WO 2005032524A2 · 2005 [cited by applicant]
WO 2005032524A3 · 2005 [cited by applicant]
WO 2005018697A3 · 2005 [cited by applicant]
WO 2005115245A1 · 2005 [cited by applicant]
WO 2006000229A2 · 2006 [cited by applicant]
WO 2006000229A3 · 2006 [cited by applicant]
WO 2007027675A1 · 2007 [cited by applicant]
WO 2007115259A2 · 2007 [cited by applicant]
WO 2008051889A1 · 2008 [cited by applicant]
WO 2008115536A2 · 2008 [cited by applicant]
WO 2009029958A2 · 2009 [cited by applicant]
WO 2013064745A1 · 2013 [cited by applicant]
WO 2014138214A1 · 2014 [cited by applicant]
WO 2014144066A1 · 2014 [cited by applicant]
Hosseinzadeh et al. (International Journal of Nanomedicine 2012 7:1851-1863 (Year: 2012). [cited by examiner]
Tsai et al. Chemical and Pharmaceutical Bulletin 2010 58(11):1461-1465 (Year: 2010). [cited by examiner]
Chinese Office Action in CN Application No. 202110670327.X, dated Jul. 20, 2023 (16 pages, with English translation). [cited by applicant]
Pharmaceutical Excipients, Luo Mingsheng et al., Sichuan Science and Technology Publishing House, Jan. 31, 2006. [cited by applicant]
Canadian Office Action for CA Application No. 3,173,027 mailed Oct. 20, 2023 (5 pages). [cited by applicant]
Galin et al. “Oral Urea as an Osmotic Ocular Hypotensive Agent,” AMA Arch Ophthalmol. 1959: 662(6), pp. 1099-1100. [cited by applicant]
Gontero, P. et al. (Sep. 2013). “The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guérin Instillation Therapy on the Quality of Life in Patients with Nonmuscle Invasive Bladder Cancer: Results of a … [cited by applicant]
Hertel, L.W. et al. (1996). “Chapter 19—Synthesis and Biological Activity of 2′,2′-Difluorodeoxycytidine (Gemcitabine),” Biomedical Frontiers of Fluorine Chemistry 639:265-278. [cited by applicant]
Kuznecov, S.A. (2000). Sankt-Peterburg. [cited by applicant]
International Search Report and Written Opinion for PCT/US2014/051672, mailed Jan. 16, 2015 (11 pages). [cited by applicant]
Amark, et al., “Follow-Up of Long-Time Treatment with Intravesical Oxybutynin for Neurogenic Bladder in Children,” European Urology, vol. 34 (1998), pp. 148-153. [cited by applicant]
Au, et al., “Methods to Improve Efficacy of Intravesical Mitomycin C: Results of a Randomized Phase III Trial,” J. National Cancer Institute, vol. 93, No. 8 (Apr. 18, 2001). [cited by applicant]
Bade, et al., “A Placebo-Controlled Study of Intravesical Pentosanpolysulphate for the Treatment of Interstitial Cystitis,” British J. Urology, vol. 79 (1997), pp. 168-171. [cited by applicant]
Beiko, et al., “Urinary Tract Biomaterials,” J. Urology, vol. 171 (Jun. 2004), pp. 2438-2444. [cited by applicant]
Birch, et al., “Absorption Characteristics of Lignocaine Following Intravesical Instillation,” Scand J Urol Nephrol, vol. J8 (1994), pp. 359-364. [cited by applicant]
Burmeister, et al., Intravesical instillation of trospium chloride, oxybutynin and verapamil for relaxation of the bladder detrusor muscle. A placebo controlled, randomized clinical test, Arzneimittelforschung, vol. 48,… [cited by applicant]
Carr, et al., “Evaluation of a transoral delivery system for topical anesthesia,” J Am Dent Assoc, vol. 132 (2001), pp. 1714-1719. [cited by applicant]
Clemens, et al., “Interstitial Cystitis and Painful Bladder Syndrome,” Urological Diseases in America, (2007), pp. 125-154. [cited by applicant]
Collins, et al., “How Common is Prostatitis? A National Survey of Physician Visits,” J. Urology, vol. 159 Apr. 1998), pp. 1224-1228. [cited by applicant]
Curhan, et al., “Epidemiology of Interstitial Cystitis: A Population Based Study,” J. Urology, vol. 161 (Feb. 1999), pp. 549-552. [cited by applicant]
Dentipatch {lidocaine) Patch [Noven Pharmaceuticals, Inc.], downloaded from http://dailymed.nlm.nih.gov/ :dailymed/fdaDrugXsl.cfm?id=1543&type=display on Feb. 22, 2007. [cited by applicant]
Erickson, et al., “Interstitial Cystitis,” Int Urogynecol J, vol. 9 (1998), pp. 174-183, Springer-Verlag London Ltd. [cited by applicant]
Estebe, et al., “Alkalinization of Intracuff Lidocaine: Efficacy and Safety,” Anesth Analg, vol. 101 (2005), pp. 1536-1541, International Anesthesia Research Society. [cited by applicant]
Fraser, et al., “The Future of Bladder Control—Intravesical Drug Delivery, a Pinch of Pepper, and Gene Therapy,” Reviews in Urology, vol. 4, No. 1 (2002). [cited by applicant]
Gammaitoni, et al., “Safety and Tolerability of the Lidocaine Patch 5%, a Targeted Peripheral Analgesic: A Review Jt the Literature, ” J Clin Pharmacol, vol. 43 (2003), pp. 111-117, American College of Clinical Pharmaco… [cited by applicant]
Gasion, et al., “Improving Efficacy of Intravesical Chemotherapy,” European Urology, vol. 50 (2006), pp. 225-234, Elsevier B.V. [cited by applicant]
Giannantoni, et al., “New Frontiers in Intravesical Therapies and Drug Delivery,” European Urology, vol. 50 (2006), pp-1183-93, Elsevier B.V. [cited by applicant]
Grayson, et al., Molecular release from a polymeric micro reservoir device: Influence of chemistry, polymer ,welling, and loading on device performance, J_ Biomed Mat Res, vol. 69A, No. 3 (2004), pp. 502-512. [cited by applicant]
Henry, et al., “Alkalinized Intravesical Lidocaine to Treat Interstitial Cystitis: Absorption Kinetics in Normal and nterstitial Cystitis Bladders,” Urology, vol. 57, Supplement 6A (Jun. 2001), p. 119. [cited by applicant]
Highley, et al., “Intravesical Drug Delivery Pharmacokinetic and Clinical Considerations,” Clinical Pharmacokinetic, vol. 37, No. 1 (Jul. 1999), pp. 59-73, Adis International Limited. [cited by applicant]
Jiranantarat, et al., “Analgesic Effect of Intraperitoneal Instillation of Bupivacaine for Postoperative Laparoscopic : Cholecystectomy,” J Med Assoc Thai, vol. 85, Suppl. 3 (Sep. 2002), pp. S897-S903. [cited by applicant]
Kim, et al., “Antimuscarinic Agents Exhibit Local Inhibitory Effects on Muscarinic Receptors in Bladder-Afferent Pathways,” Urology, vol. 65, No. 2 (2005), pp. 238-242, Elsevier Inc. [cited by applicant]
Larsson, et al., “Effect of Intraperitoneal Instillation of 32% Dextran 70 on Postoperative Adhesion Formation After Tubal Surgery,” Acta Obstet Gynecol Scand, vol. 64 (1985), pp. 437-441. [cited by applicant]
Li, et al., “Water Based Silicone Elastomer Controlled Release Tablet Film Coating III—Drug Release Mechanisms,” Drug Development and Industrial Pharmacy, vol. 15, No. 12 (1989), pp. 1943-1968, Marcel Dekker, Inc. [cited by applicant]
Malmstrom, Per-Uno, “Intravesical therapy of superficial bladder cancer,” Critical Reviews in Oncology Hematology, vol. 47 (2003), pp. 109-126, Elsevier Science. [cited by applicant]
Morimoto, et al., “Management of Patients with Recurrent Nephrosis and Intractable Edema by Intraperitoneal Instillation of Icodextrin Solution,” Peritoneal Dialysis International, vol. 28, No. 5 (Sep. 2008), pp. 559-56… [cited by applicant]
Parsons, C. Lowell, “Successful Downregulation of Bladder Sensory Nerves with Combination of Heparin and I Ikalinized Lidocaine in Patients with Interstitial Cystitis,” Urology, vol. 65, No. 1 (2005), pp. 45-48. [cited by applicant]
Russell, et al., “High-performance liquid chromatographic determination of 17B-estradiol and 17B-estradiol-3-acetate solubilities and diffusion coefficients in silicone elastomeric intravaginal rings,” J. Chromatography… [cited by applicant]
Saitoh, et al., “Effects of Intravesical Instillation of Resiniferatoxin on Bladder Function and Nociceptive Behavior in Freely Moving, Conscious Rats,” J. Urology, vol. 179 (Jan. 2008), pp. 359-364, American Urological… [cited by applicant]
Santus, et al., “Osmotic drug delivery: a review of the patent literature,” J. Controlled Release, vol. 35 (1995), pp. 1-21. [cited by applicant]
Spratt, et al., “Clinical Delivery System for Intraperitoneal Hyperthermic Chemotherapy,” Cancer Research, vol. 40 (Feb. 1980), pp. 256-260. [cited by applicant]
Theeuwes, Felix, “Elementary Osmotic Pump,” J. Pharm Sci, vol. 64, No. 12 (Dec. 1975), pp. 1987-1991. [cited by applicant]
Theoharides, et al., “Painful Bladder Syndrome/Interstitial Cystitis: Current Concepts and Role of Nutraceuticals,” Seminars in Preventive and Alternative Medicine, vol. 2 (2006), pp. 6-14, Elsevier Inc. [cited by applicant]
Thombre, et al., “Mechanism of Water Transport in Controlled Porosity Osmotic Devices,” J. Membrane Science, vol. 40 (1989), pp. 279-310, Elsevier Science Publishers B.V. [cited by applicant]
Tyagi, et al., “Local Drug Delivery to Bladder Using Technology Innovations,” Urological Clinics of North America, vol. 33 (2006), pp. 519-530, Elsevier Inc. [cited by applicant]
Vassileva, et al., “Novel biocompatible intraperitoneal drug delivery system increases tolerability and therapeutic efficacy of paclitaxel in a human ovarian cancer xenograft model,” Cancer Chemother Pharmacol, vol. 60 … [cited by applicant]
Verma, et al., “Formulation aspects in the development of osmotically controlled oral drug delivery systems,” J. Controlled Release, vol. 79 (2002), pp. 7-27, Elsevier Science B.V. [cited by applicant]
Walker, et al., “Intravesical Chemotherapy: In Vitro Studies on the Relationship Between Dose and Cytotoxicity,” Urological Research, vol. 14 (1986), pp. 137-140, Springer-Verlag. [cited by applicant]
Walter, et al., “Bioavailability of Trospium Chloride Aller Intravesical Instillation in Patients with Neurogenic Lower Urinary Tract Dysfunction: A Pilot Study,” Neurourology and Urodynamics, vol. 18 (1999), pp. 447-45… [cited by applicant]
Woolfson, et al., “Design of a silicone reservoir intravaginal ring for the delivery of oxybutynin,” J. Controlled Release, vol. 91 (2003), pp. 465-476, Elsevier B.V. [cited by applicant]
Woolfson, et al., “Design of an intravaginal ring for the controlled delivery of 17B-estradiol as its 3-acetate ester,” J. Controlled Release, vol. 61 (1999), pp. 319-328, Elsevier Science B.V. [cited by applicant]
Wright, et al., Pumps/Osmotic, Encyclopedia of Controlled Drug Delivery, vol. 2 (1999), pp. 896-920, New York; John Wiley. [cited by applicant]
Wright, et al., “DUROS® Osmotic Pharmaceutical Systems for Parenteral & Site-Directed Therapy,”, Drug Delivery Technologies: Implantable Technology, vol. 3, No. 1, 2003, pp. 1-15 {http://www.drugdeliverytech.com/cgi-bin… [cited by applicant]
Australian Office Action for AU Application No. 2014309012 mailed Jul. 20, 2018 (3 pages). [cited by applicant]
Chinese Office Action for CN Application No. 201480044009.0 mailed Jun. 28, 2018 (13 pages). [cited by applicant]
Japanese Office Action for JP Application No. 2016-536377 mailed Jun. 28, 2018 (6 pages with English translation). [cited by applicant]
Russian Office Action for RU Application No. 20116108968/14 mailed Jun. 26, 2018 (14 pages with English translation). [cited by applicant]
Singh et al., Osmotic Pump Drug Delivery System: A Noval Approach, J. Drug Delivery & Therapeutics, 3(5) 156-62 2013). [cited by applicant]
Theeuwes, F. et al. “Principles of the Design' and Operation of Generic Osmotic Pumps for the Delivery of Semisolid or Liquid Drug Formulations”, Annals of Biomedical Engineering, 1976, 4(4): pp. 343-353. [cited by applicant]